Aside from repeating my observation that CytoDyn c
Post# of 155346
(Total Views: 649)
Posted On: 10/20/2020 6:48:38 AM
Aside from repeating my observation that CytoDyn could have now been at 302 patients if they had just applied the enrollment leverage they claim to currently have:
Source Link: https://investorshangout.com/post/view?id=5933801
I think the two big questions are:
1. Will the next interim analysis occur when enrollment reaches the 75% level of 293 patients (as the press release indicates) -- or will it occur when the 293rd patient has reached 28 or 42 days?
2. We have seen the positive statistical effect of gauging survival for longer durations. With the analysis of survival at 42 days now being included in the next interim analysis, we need to know if the treatment arm has been provided with leronlimab between Day 28 and Day 42, or if leronlimab was stopped at Day 28.
This is what the protocol states:
Source Link: https://investorshangout.com/post/view?id=5933801
I think the two big questions are:
1. Will the next interim analysis occur when enrollment reaches the 75% level of 293 patients (as the press release indicates) -- or will it occur when the 293rd patient has reached 28 or 42 days?
2. We have seen the positive statistical effect of gauging survival for longer durations. With the analysis of survival at 42 days now being included in the next interim analysis, we need to know if the treatment arm has been provided with leronlimab between Day 28 and Day 42, or if leronlimab was stopped at Day 28.
This is what the protocol states:
Quote:Source Link: https://clinicaltrials.gov/ct2/show/NCT04347239
Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.
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